Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162091
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-11-30
Brief Title:
Modeling Outcome in Patients With Acquired Brain Injuries
Sponsor:
Istituto per la Ricerca e lInnovazione Biomedica
Organization:
Istituto per la Ricerca e lInnovazione Biomedica
Study Overview
Official Title:
Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOF-ABI
Brief Summary:
Acquired brain injury ABI is the leading cause of death and disability worldwide The degree of severity varies according to a combination of numerous demographics etiological clinical cognitive behavioral psychosocial and environmental factors which can interfere with the effectiveness of rehabilitation interventions and therefore with the final outcome
The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach
In recent years artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome The classical approach of these algorithms provides only probabilistic values on the final outcome without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period
The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period The proposed approach combines a principal component analysis PCA for dimension reduction capturing the maximum amount of information and reducing the dimensionality problem and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions By using this approach we may determine the individual patients temporal trajectories while examining particular clinical factors The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index ERBI a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury
The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach
In recent years artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome The classical approach of these algorithms provides only probabilistic values on the final outcome without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period
The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period The proposed approach combines a principal component analysis PCA for dimension reduction capturing the maximum amount of information and reducing the dimensionality problem and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions By using this approach we may determine the individual patients temporal trajectories while examining particular clinical factors The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index ERBI a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None